CTRI/2019/10/021699
Completed
未知
Evaluation of Dermatological safety of Investigational products by primary irritation patch test onhealthy human volunteers of varied skin types
ITC Life Sciences Technology Centre0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Life Sciences Technology Centre
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy male and female subjects in the age group of 18\-55 years(both age inclusive)
- •2\. Subjects with Fitzpatrick skin type III to V
- •3\. Subjects willing to give a voluntary written informed consent
- •4\. Subjects willing to maintain the test patches in designated
- •positions for 24 Hours
- •5\. Subjects having not participated in a similar investigation in the
- •past two weeks
- •6\. Subjects willing to come for regular follow up visits
- •7\. Subjects ready to follow instructions during the study period
- •8\. Subjects without any open wounds, cuts, abrasions, irritation
Exclusion Criteria
- •1\. Subjects with Infection/ allergy/ irritation symptoms on the upper
- •back area identified for patch application
- •2\. Subjects with any kind of skin allergy, antecedents or atopy or
- •cutaneous disease which may influence the study results
- •3\. Subject is Pregnant or Lactating
- •4\. Athletes and subjects with history of excessive sweating
- •5\. Subjects on oral corticosteroid, or using any topical or systemic
- •medicine which might interfere with the study results
- •6\. Subjects participating in any other cosmetic or therapeutic trial
- •7\. Subjects with any history of underlying uncontrolled medical
Outcomes
Primary Outcomes
Not specified
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